The Recall Desk
SevereFDA (Devices)·Z-2140-2023·Announced 2023-08-02

HAMILTON T1 Ventilator software defect may cause unexpected shutdown

Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification for a critical medical device. A software defect causing ventilator shutdown after approximately 91 days of use poses serious risk to ventilator-dependent patients.

Plain-English summary

Hamilton Medical, Inc. is recalling 2,319 HAMILTON T1 Ventilators, which provide positive pressure ventilatory support to adults, children, infants, and neonates.

The recall is due to a software anomaly. After approximately 91 days of cumulative use, affected ventilators may stop and enter ambient mode without warning. This unexpected shutdown could interrupt critical respiratory support to dependent patients.

The affected ventilators have been distributed throughout the United States, Puerto Rico, Bahamas, Japan, and Mexico. Specific serial numbers have been identified as part of this recall.

Patients and healthcare providers should verify their ventilator serial numbers against the manufacturer's list and contact Hamilton Medical, Inc. for further guidance.

The recalled product

Product
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Manufacturer
Hamilton Medical, Inc.
Category
Medical Device — Mechanical Ventilator
Hazard
  • software-defect
  • device-malfunction

Distribution

Distribution scope not specified by the agency.

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